JP2023512755A - Method and apparatus for supporting a U-shaped portion of an elongated flexible element against body tissue - Google Patents

Abstract

An apparatus and method for engaging a U-shaped portion of an elongated flexible element. The device has a body with a fixed part, a passageway extending to the fixed part, and an entrance opening to the passageway. When the U-shaped portion and the body are in operative relationship, the U-shaped portion straddles the fixation portion and can apply tension to the elongated flexible element to pull the face of the body against tissue. so as to alter the size/or shape of the inlet opening and/or the passageway to avoid part or all of the U-shaped portion separating from the body when the U-shaped portion straddles the fixed portion; The body can be reconfigured.

Description

FIELD OF THE INVENTION The present invention relates to an elongated flexible element guided into a passageway through human tissue, and more particularly to prevent the exposed portion of the elongated flexible element from being pulled through and into the passageway. , relates to methods and apparatus for engaging a portion of an elongated flexible element exposed on one side of tissue.

A wide variety of surgical procedures are performed using elongate flexible elements projecting from one side of a tissue passageway. This must be prevented as the retraction of the protrusions of the flexible element into the passageway can cause the protrusions to retract into the tissue passageway. Such procedures are performed using sutures or other types of elongated flexible elements.

One conventional method of preventing retraction of a protruding flexible element is to place one or more bodies against the surface of the tissue and support the protruding portion of the flexible element with the body(s). be. The geometry of the body prevents the body from moving into the passageway in its operating position. This body thus performs a bracing function and also distributes the forces generated by the protrusions of the flexible element over a larger area to avoid stress concentrations that can exacerbate the problem.

Although the present invention relates to procedures involving flexible elongated elements of various types, the focus here is on flexible elongated elements in the form of sutures. It is understood that this is merely exemplary in nature and that the analysis of the prior art and the present invention is relevant to various types of elongated flexible elements as well.

Similarly, references to "tissue" are not limited to either hard or soft tissue. Each procedure involves guiding a suture through a single tissue, hard or soft, or a combination of all hard or soft tissues, or a combination thereof.

In many of these conventional procedures, a "button" is placed distally on the side of the tissue from which the suture protrudes, where it is necessary to manipulate the protruding suture section. A suture is placed in an operative position relative to the button and the button is guided through a passageway in the tissue to expose the button and a portion of the suture retained therein on the side of the tissue where the suture is manipulated. It is known. Buttons can be rationally designed to travel in one direction through a relatively small passageway and be placed in another direction across the passageway to prevent being pulled therefrom, but best , the passageway in which the button must be accommodated must be relatively large. This can be a problem, especially in procedures where such channel formation may render certain bones susceptible to fracture. Additionally, ossicles may not be suitable for forming a sufficient diameter to allow this type of button to pass through. In general, the goal in all procedures is to minimize as much as possible the size of the passageway through which the sutures need to extend.

With this latter purpose in mind, many procedures are performed by leading only the suture into the passageway and exposing it on the side to which the button, other weight distribution material or anchoring structure is attached. One common approach is to configure the suture so that the U-shaped portion protrudes from the tissue passage where manipulation of the suture is required. This can be accomplished by folding the suture itself in half and advancing the formed suture through the passageway in a direction that drags the "U" shaped opening. In one form, this involves forming a continuous loop that is directed through the passageway until the tip of the loop is exposed in a "U" shape. The button is then attached from the side from which the suture protrudes.

Several objectives, often mutually exclusive, must be considered when designing this remote button. First, surgeons seek structures that can be easily and consistently attached to sutures. At the same time, this connection must have a high level of integrity. Failure to meet the former objective can result in procedural inefficiency, frustration and increased fatigue for the surgeon. Failure to effectively achieve the latter goal can have serious health consequences for the patient.

One existing button design is characterized as a "dogbone". The button has longitudinal ends with oppositely opening slots, one on each end. This button has some type of holder for easy use by the surgeon when feeding sutures into its two end slots. In this design, the surgeon applies tension to the suture to draw its U-shaped portion to the button so that the legs of the "U" do not escape from the end slots and the button is eventually pressed against the underlying tissue. It is necessary to Generally, the suture remains within the end slots as long as there is tension on the suture.

In this common design, the "U" portion of the engaged suture tends to spread out in the width direction, so dog bones are used to reduce the risk of the suture escaping one or both of the button end slots. Buttons should be large enough. In general, the larger the structure, the greater the irritation to the underlying soft tissue. Furthermore, in certain applications, such as thumb CMC bonding, the pressure on this button must be minimal so that the suture remains prone to separation from the button even upon completion of the procedure.

The medical field continues to seek improved surgical devices and methods to better address the above areas.

In one form, the invention provides for engaging a U-shaped portion of an elongated flexible element with a device such that said U-shaped portion of said elongated flexible element acts to align a body on said device with the body. It relates to a method of making it possible to hold in part. The U-shaped portion of the elongated flexible element has a base and first and second legs spaced apart and extending away from the base and having first and second lengths, respectively. have. The method includes obtaining the device. The body of the device a) has a tissue adhering side and an opposing side, and b) is changeable between a first state and a second state. The body of the device includes a fixed portion and a first passageway extending along a portion of the body to the fixed portion and having a first inlet opening. The method further includes relatively moving the U-shaped portion of the elongated flexible element and the body from a starting relationship to an operating relationship when the body is in the first state; The first and second legs can straddle the securing portion and pull the bottom portion against the securing portion to bias the tissue adhering surface of the body toward the portion of the body. Relatively moving the U-shaped portion of the elongated flexible element and the body moves at least a portion of the U-shaped portion of the elongated flexible element through the first inlet opening. moving into said first path and moving within said first path to said fixed part. The method further comprises changing the body to the second state when the body is in the first state and the body and the U-shaped portion of the elongated flexible element are in the operative relationship. Including process. The step of changing the body to the second state includes moving at least a portion of the U-shaped portion toward and through the first inlet opening to the first inlet opening. at least one of i) dimensions and ii) shape of said first inlet opening and/or said first passage so as to prevent it from moving away from said fixed part in the passage of Including changing.

In one form, at least a portion of said U-shaped portion of said elongated flexible element is moved through said first inlet opening into said first path and within said first path The step of moving to the fixed portion moves at least one of the first and second legs through the first inlet opening into the first path and within the first path. including moving to the fixed part.

In one form, the method includes applying tension to the U-shaped portion of the elongate flexible element when the U-shaped portion of the elongated flexible element and the body are in operative relationship, thereby tensioning the bottom portion. against the anchor to bias the tissue adhesive surface of the body against the portion of the anatomy.

In one form, the method further comprises the step of tensioning and securing said elongated flexible element, thereby maintaining a particular force of said tissue adhering surface of said body against said portion of said human body. include.

In one form, the body comprises a second path extending along a portion of the body to the anchor. The step of relatively moving the U-shaped portion and the body of the flexible element moves the first leg within the first path to the fixed portion and the second leg. within the second path to the fixed portion.

In one form, the body comprises a second inlet opening spaced from the first inlet opening. The step of relatively moving the U-shaped portion and the body of the flexible element includes moving the second leg through the second inlet opening.

In one form, said step of relatively moving said U-shaped portion and said body of said flexible element moves said first and second legs through said first inlet opening to said second leg. including moving within one path.

In one form, the first and second paths are in communication with each other when the body is in the first state.

In one form, communication between the first path and the second path is blocked when the body is in the second state.

In one form, the method reconfigures the body by moving a first portion of the body relative to another portion of the body, thereby moving the body from the first state to the second state. further comprising the step of changing the state of

In one form, the step of moving the first portion of the body deforms the body, thereby changing the relationship between the first portion of the body and another portion of the body. including letting

In one form, a portion of the body and another portion of the body are defined by a single piece.

In one form, when the body is in the second state, at least one of the first leg and the second leg within the first path is positioned within the first path. The inlet opening is substantially completely blocked to prevent movement to and through the first inlet opening.

In one form, the method further includes changing the body from the first state to the second state by crimping opposing regions of the body.

In one form, the tissue adhering surface of the body has a first substantially planar surface.

In one form, said opposite side of said body has a second substantially planar surface. The first and second substantially planar surfaces lie in first and second substantially parallel planes.

In one form, the elongated flexible element is a suture.

In one form, the first portion is a cantilever.

In one form, the device further comprises an elongated handle secured to the body, and further comprising the step of manipulating the handle to change the position of the body.

In one form, the method further includes separating the handle from the body.

In one form, the step of separating the handle from the body includes breaking a frangible connection between the handle and the body.

In one form, the method further includes reconfiguring the body using a crimping tool to change the body from the first state to the second state.

In one form, the crimping tool is a surgical needle holder.

In one form, the method comprises advancing the body into a passageway of the portion of the human body when the U-shaped portion of the elongated flexible element and the body are in the operative relationship, and concomitantly: Further comprising changing the body from the first state to the second state.

In one form, the present invention is an elongated flexible element and device combination, wherein the elongated flexible element is navigable into body tissue and configured to define a U-shaped portion projecting from said body tissue. A flexible element comprising a base and first and second legs spaced apart and projecting away from the base, each leg having a length extendable into the body tissue. and a body having a tissue adhering surface and an opposite surface, said body having first and second pathways and between said first and second pathways. and a fixed portion having a bearing surface at the bottom, wherein said first and said second passages have respective first and second inlet openings. The body moves a) an intermediate length of the first leg into the first path through the first inlet opening, and b) an intermediate length of the second leg. moving a scabbard into said second path through said second inlet opening, and c) said bottom of said U-shaped portion overlying said bearing surface, said U-shaped portion and said body; The body and the elongated flexible element are configured to be relatively movable from a starting relationship so that are in a pre-operative relationship. said first leg by moving said first leg and said second leg away from each other in a single plane when said U-shaped portion and said body are in said pre-operating relationship; the body is configured such that the body prevents both the leg from moving out of the first path and the second leg from moving out of the second path. there is Thereby, when said U-shaped portion and said body are in said preliminary operational relationship, said U-shaped portion and said body are brought into a final operational relationship in which said bottom portion of said U-shaped portion is moved relative to said bearing surface. The elongated flexible element can be moved to change the .

In one form, the body has an S-shaped portion extending around the first pathway and the second pathway.

In one form, the securing portion comprises an elongated member having a length extending along a first line. A reference plane perpendicular to said line extends without passing through both the first inlet opening and the second inlet opening.

In one form, the securing portion is defined by an elongated member having a length extending along the first line. A reference plane perpendicular to the first line extends without passing through either the first inlet opening or the second inlet opening.

In one form, the device further comprises an elongated handle fixedly connected to the body and grippable and repositionable to move the body.

In one form, the elongated handle is joined to the body by a frangible connection.

In one form, each of said inlet openings has an inlet width and the length of said elongated member is greater than said inlet width of each of said first inlet opening and said second inlet opening.

In one form, the first and second inlet openings are on opposite sides of a reference plane that bisects the length of the elongated member and is perpendicular to the first line.

In one form, the tissue adhering surface of the body is defined by a substantially flat surface.

In one form, the body is made of a metallic material.

In one form, the present invention is an elongated flexible element and device combination, wherein the elongated flexible element is navigable into body tissue and configured to define a U-shaped portion projecting from said body tissue. A flexible element comprising a base and first and second legs spaced apart and projecting away from said base, each of said legs having a length extendable into said body tissue. and a body having a tissue adhering surface, said body having a securing portion and a first path extending along a portion of said body to said securing portion. and a device comprising The device is capable of relative movement of the U-shaped portion of the elongated flexible element and the body from a starting relationship to an operating relationship when the body is in a first state, wherein the first and A second leg straddles the fixed portion and at least a portion of the U-shaped portion of the elongated flexible element moves through the first inlet opening into the first path and As a result, it is possible to move in the first path to the securing portion and pull the bottom portion against the securing portion to bias the first surface of the body toward the portion of the human body. configured to allow The body has a portion movable toward another portion of the body, thereby placing the body in a second state, wherein the at least a portion of the U-shaped portion extends into the first inlet opening. said first inlet opening and/or said first inlet opening so as to impede movement towards and through said first inlet opening and away from said fixed part in said first path. At least one of i) dimensions and ii) shape of one path is changed.

In one form, the body comprises a second passageway extending along a portion of the body to a second inlet opening.

In one form, the movable portion of the body is movable by deforming the body.

In one form, the movable portion is a deformable cantilever.

In one form, the body defines a second path extending along a portion of the body to the anchor.

In one form, the body defines a second inlet opening to the second pathway.

In one form, said body has a second portion that is movable towards another portion of said body, whereby said second inlet opening and/or said second passage have a) dimension , and b) the shape is changed.

In one form, the body is "U" shaped.

1 shows in schematic form a device for supporting a U-shaped portion of an elongated flexible element against human tissue, and the elongated flexible element in which the device is used; FIG. 1 is a fragmentary, partial cross-sectional view of tissue with a passageway and an elongated flexible element in the form of a suture, the elongated flexible element having a U-shaped portion protruding through the passageway and into the passageway; and by preventing it from being drawn through the passageway. 3 is a view of a suture formed into a continuous loop to create the U-shaped portion of FIG. 2; FIG. FIG. 3 is a view similar to FIG. 2 showing the prior art device connected to the protruding U-shaped portion to prevent the U-shaped portion from being pulled into and through the passageway; 5 is a plan view of the device of FIG. 4 with suture wrapped around it; FIG. FIG. 3 is a perspective view of the device of the present invention with a U-shaped section of suture aligned to be moved to a pre-operative position and a graspable handle that can be used to change the position of the body on the device; is. 7 is a plan view of the body on the device of FIG. 6 with the handle removed and the suture in its final operating position; FIG. FIG. 5 is a view similar to FIG. 4 with the U-shaped portion of the suture in a pre-actuated position relative to the device body of the present invention; FIG. 8 is a view similar to FIG. 8 with the U-shaped section changed to the final operating position of FIG. 7; FIG. 8 is a view similar to FIG. 7 in which a portion of the body has been deformed to change the shape and dimensions of the entrance opening to the channel of the body and of the channel; Figure 7 is a partial side view of the frangible connection between the handle and body of Figure 6, with the handle disconnected from the body; 11 is a plan view of a conventional surgical needle holder that can be used to reconfigure the body as shown in FIG. 10; FIG. Fig. 10 is an exploded schematic view partially showing another form of instrument according to the present invention, showing the body in a first state, the associated elongated flexible elements, and the tissue having passageways through which they pass; FIG. 14 is a view similar to FIG. 13 with the members assembled and the body guided through the tissue passageway in a second condition; 14 is a view corresponding to FIG. 13 of a variant of the body in the same state as in FIG. 13; FIG. FIG. 4 is an exploded perspective view of another form of instrument body according to the present invention, wherein the body is in a starting relationship with a U-shaped portion on an elongated flexible element; FIG. 17 is a view similar to FIG. 16 with separate U-shaped portions on the elongated flexible element and the body in operative relationship in the state of the body of FIG. 16; FIG. 18 is a view similar to FIG. 17 with the state changed from that of FIGS. 16 and 17 by crimping the body; Fig. 10 is an exploded schematic view, partially showing a further configuration of an instrument body according to the invention in starting relationship with a U-shaped portion on an elongated flexible element; FIG. 20 is a view similar to FIG. 19 with the U-shaped portion of the elongated flexible element and the body placed in operative relationship and the body reconfigured to change its state;

In FIG. 1, a device 10 consisting of a body 12 having a tissue adhesive side/surface 14 and an opposing side/surface 16 is shown in schematic form. Tissue-adhesive surface 14 may be substantially flat or may form a contour designed to engage against a tissue surface. Body 12 has at least one channel 18 that extends along a portion of body 12 to anchor 20 . At least one passageway 18 has an inlet opening 22 . Multiple pathways 18 may be provided with separate or common inlet openings. The fixed part 20 may consist of one or more parts and defines at least one bearing surface 21 .

An optional grippable handle 24 is provided and attached to the body 12 to reposition the body 12 and facilitate handling.

Also shown schematically in FIG. 1 is an elongated flexible element 28 for use in conjunction with device 10 . Flexible elongated element 28 is any elongated flexible element primarily surgically attached to human tissue, whether soft or hard, and has a U-shaped portion 30 which, in use, protrudes from a passageway in the tissue. and controlled in terms of tissue to avoid being drawn into and through the passageway. U-shaped portion 30 typically forms part of a closed loop. However, this is not mandatory. The schematic diagram showing flexible elongated element 28 is intended to encompass virtually any type of flexible elongated element used in a medical procedure to pass through a single tissue or multiple tissues. there is For simplicity, elongated flexible element 28 is identified as a suture throughout the description and claims herein. The suture is a representative construct intended to be the equivalent of any elongated flexible element used in surgical procedures such as, but not limited to, tendon grafting. understood.

Device 10 is configured to cooperate with U-shaped portion 30 projecting from the tissue passageway. U-shaped portion 30 comprises a bottom portion 32 and first and second legs 34 and 36 projecting spaced apart from bottom portion 32 . Legs 34 and 36 each have a length.

The body 12 is configured such that the body 12 and the U-shaped portion 30 of the elongated flexible element 28 can move relative to each other from a starting relationship, which is a fully separated relationship, to an operating relationship. In operative relationship, the first leg 34 and the second leg 36 straddle the fixed portion 20 and pull the bottom portion 32 against the bearing surface 21 of the fixed portion 20 to bring the tissue adhesive surface 14 of the body 12 into contact with the body. A portion can be biased.

Body 12 may be used in a single state or may be reconfigured to change from a first state to a second state. In the second condition, to avoid inadvertent partial or complete separation of the U-shaped portion 30 from the body 12, one or more of the inlet openings 22 and/or passages 18 are Dimensions and/or shape are altered.

Alternatively, reconfiguration of body 12 may not necessarily be performed. Body 12 in one such type can be moved such that first leg 34 and second leg 36 move away from each other in a single plane, with U-shaped portion 30 in the pre-operating position. body 12 is configured to prevent movement of first leg 34 out of first path 18a and movement of second leg 36 out of second path 18b.

With this construction, movement of the elongated flexible element 28 in the preliminary operating position changes the U-shaped portion 30 to the final operating position in which the bottom 32 of the U-shaped portion 30 acts against the bearing surface 21, thereby can bias the tissue-adhesive surface 14 of the body 12 against or toward body tissue in which the passageway is formed.

In certain procedures, the body 12 is pulled against tissue and the tissue is urged against yet another body part. In other procedures, body 12 limits the distance that associated tissue can be separated from another body part. In the latter case, with the U-shaped portion 30 in its final operating position, the body 12 may be biased with limited pressure against the tissue of interest, or may be completely spaced from the tissue of interest. , may engage the relevant tissue only to stabilize the relevant tissue or to limit movement of the relevant tissue away from another body part. The present invention encompasses both types of treatment, but will be described primarily with respect to the former throughout.

The schematic diagram of FIG. 1 is intended to encompass a variety of virtually unlimited configurations for each component shown therein and their interaction. The following description is intended to represent only certain structures and method steps that can be performed in accordance with the present invention.

FIG. 2 shows a typical U-shaped portion 30 on elongated flexible element/suture 28 . U-shaped portion 30 comprises bottom portion 32 as previously described, as well as elongated first leg 34 and elongated second leg 36 . The U-shaped portion 30 is guided through a passageway 38 defined in this case through two different overlapping tissues, 40a and 40b. As noted above, the present invention can be practiced with a single tissue, multiple tissues, all hard or soft, or a combination of hard and soft tissues.

The present invention is directed to controlling the U-shaped portion 30 of suture 28 protruding from passageway 38 beyond tissue surface 42 .

Suture 28 can be configured in a "U" shape in a variety of ways. For example, suture 28 may simply fold back on itself and in doing so can be guided through passageway 38 by pulling bottom portion 32 until exposed there through tissue surface 42 .

3, suture 28 is knotted as is conventionally done to create a closed loop 44, and U-shaped portion 30 is defined in a portion of loop 44, similar to that described with respect to FIG. manipulated.

There is no limitation as to how U-shaped portion 30 is formed or how suture 28 is controlled to provide the configuration of FIG.

4 and 5, engaging the U-shaped portion 30 of the suture so that the U-shaped portion 30 passes through the passageway 38 in the tissue 40, as described in the background section herein. A conventional "button" is indicated at 46 to prevent retraction in the direction of arrow 48 .

Button 46 consists of an elongated body 52 having oppositely opening U-shaped slots 54 and 56 at spaced apart ends.

To operatively engage button 46 with U-shaped portion 30 of suture 28, the width of U-shaped portion 30 is such that legs 34 and 36 are positioned within slots 54 and 56, as shown in dashed lines. Enlarged enough to fit one each, its bottom 32 spans between slots 54 and 56 over a surface 58 opposite surface 60 that abuts tissue surface side 42 .

U-shaped portion 30 is then reconfigured by pulling legs 34 and 36 through passageway 38 in the direction of arrow 62 and tensioning suture 28 so that bottom 32 is finally conforms to and substantially completely abuts surface 58 between slots 54 and 56 . Continued pulling on legs 34 and 36 forces suture 28 into slots 54 and 56, pulling bottom 32 against body 52, thereby stabilizing the body and/or. or surface 60 is biased against tissue 40; The increased shape of elongated body 52 prevents migration into passageway 38 , and tensioned U-shaped portion 30 is controllably secured to tissue surface 42 to distribute tension over the area of surface 60 . be.

As noted above in the description of the conventional "dogbone" button, with the suture 28 in the dotted line position of FIG. The suture legs 34 and 36 are only loosely aligned with the respective slots 54 and 56 . Therefore, the surgeon must pull the suture legs 34 and 36 while simultaneously preventing inadvertent movement of the legs 34 and 36 out of their respective slots 54 and 56. . This complicates the procedure and, as mentioned above, is a problem that can frustrate and fatigue the surgeon. Furthermore, the nature of the open slots 54 and 56 is such that the natural expansion of the U-shaped portion 30 under the residual forces encountered during bending causes the legs 34 and 36 to move out of the respective slots 54 and 56. It is easy to move. Ultimately, multiple attempts may be required to place suture 28 and button 46 in the proper operative relationship. Because slots 54 and 56 are open, suture legs 34 and 36 may be placed inconsistently therein. This is especially true for procedures that do not require the U-shaped portion 30 to be highly contracted or the suture 28 defining the U-shaped portion 32 to be placed under relatively high tension after surgery. Loosening can lead to the possibility of separation from the intended operating position.

6-12, a description of one particular exemplary form of apparatus 10 of the present invention will now be provided.

Body 12 of device 10 has a generally "S" shape when viewed from above, as approximated by dashed line 64 in FIG. This "S" shape extends around a first passageway 18a having an entrance opening 22a and a second passageway 18b having an entrance opening 22b. Body 12 has an elongated member/bar that defines a fixed portion 20 . A bearing surface 21 is defined on the fixed portion 20 between the paths 18a and 18b.

Cantilevered portions 68 and 70 project in opposite directions from opposite ends of the elongated bar-shaped ends toward the free ends of the "S", respectively, thereby limiting the width dimensions W1 and W2 of inlet openings 22a and 22b, respectively. Establish.

6 and 7, the body 12 is such that the intermediate lengths of the first leg 34 and the second leg 36 bisect the width W3 of the body 12 and the length of the fixed portion 20. Moving in opposite directions in paths P1 and P2 respectively, leg 34 enters path 20a through entrance opening 22a and leg 36 enters path 20a in a path non-parallel to the vertical reference plane RP. It is configured to enter channel 20b through opening 22b so that bottom 32 overlies bearing surface 21, as shown in FIG. This represents one pre-operating position of the U-shaped section 30 .

Beginning with legs 34 and legs 36 extending through tissue passageway 38 and U-shaped portion 30 wrapped over or against elongated securing portion 20 in the pre-operative position of FIG. , legs 34 and legs 36 are pulled in the direction of arrow 62 so that bottom 32 of suture 28 bears against bearing surface 21, U-shaped portion 30 is pulled to Take its final operating position. Tissue-adhesive surface 14 of body 12 is drawn firmly against tissue surface 42 .

As a result, U-shaped portion 30 securely holds body 12 against tissue surface 42 . In the structure of the present invention, legs 34 and 36 are positioned in respective paths 18 and 20 so that, as in the prior art structure shown in FIGS. Expanding the U-shaped portion 30 into a single plane does not make it easier to escape. More particularly, when U-shaped portion 30 is expanded at the reference plane of FIG. 7, legs 34 abut surface portions 72 surrounding passageway 18a and legs 36 abut surface portions 74 bounding passageway 18b. touch.

As seen in FIG. 7, the elongated fixation portion 20 has a length extending in a first line orthogonal to the reference plane RP and indicated by the double-headed arrow 76 . The opening 22a and the opening 22b are on both sides of the reference plane RP that bisects the length of the fixed part 20. As shown in FIG. The reference plane RP passes neither the entrance opening 22a nor the entrance opening 22b. This is true even if the reference plane is shifted to either end of the fixed part 20 .

Moreover, even if the plane of U-shaped portion 30 is shifted non-perpendicular to the length of fixed portion 20, the plane does not pass through both inlet opening 22a and inlet opening 22b.

Therefore, in order for either leg 34 or leg 36 to escape from the respective opening 22a or 22b, leg 34 or leg 36 must be pulled in the direction opposite to that indicated by arrows P1 and P2. , must be moved in an oblique path.

To align with the prior art button 46, the U-shaped portion 30 of the suture 28 could simply be enlarged and then constrained to reach its final state, whereas in the present invention, each To position the legs 34 and 36 within the paths 18a and 18b of the U-shaped portion and to engage the anchor portion 20 with the bottom portion 32 of the U-shaped portion, the suture shape and/or , and the position of body 12 and suture 28 relative to each other. As a result, the U-shaped portion 30 is less likely to inadvertently separate from the main body 12 . At the same time, by controllably moving one or both of suture 28 and body 12, suture and device 10 can be effectively placed in operative relationship. This relative movement can be effected primarily by manipulating suture 28 or body 12, or by moving both in a coordinated manner.

As an example, the U-shaped portion 30 can be generally aligned as shown in FIG. This allows the legs 34 to be guided through the inlet opening 22 and then the angular position of the body 12 to be changed to align the legs 36 with the inlet opening 24 . Legs 34 and 36 are guided through respective openings 22 and 24, into respective channels 18a and 18b, and against fixed portion 20 as bottom portion 32 and fixed portion 20 are guided. Legs 34 and 36 can be pulled to bias against.

Of course, it is contemplated that the free ends of suture legs 34 and 36 may be directed into channels 18a and 18b to place U-shaped portion 30 in its pre-operative position.

As shown in FIG. 8, an intermediate length of first leg 34 travels through inlet opening 22a into channel 18a and an intermediate length of second leg 36 passes through the second inlet opening. When moved through portion 22b and into channel 18b, bottom portion 32 overlaps bearing surface 21 on the fixed portion and U-shaped portion 30 is in a pre-operating position.

U-shaped portion 30 is then changed to the final operating position of FIGS. 7 and 9 by pulling legs 34 and 36 away from the passageway in the direction of arrow 62 . Bottom portion 32 is pulled against bearing surface 21 , thereby urging tissue adhesive surface 14 of body 12 against surface 42 of body tissue 40 .

As seen most clearly in FIG. 6, all edges of body 12 are rounded to prevent suture snagging as suture 28 is slid. At the same time, this reduces the likelihood that the edges against which the sutures 28 abut will become damaged or split during the procedure or as body tissue moves over time after the procedure is completed.

In addition, the relatively small effective diameter of elongated member 66 allows suture 28 to fit over fixation portion 20 and guide legs 34 and 36 thereon away into passageway 38 . Therefore, the severity of bending of the suture can be reduced.

To further reduce the likelihood of any portion of suture 28 being unintentionally separated from body 12 when the U-shaped portion is in the pre-operative position, body 12 is reconfigured to provide access to the entry opening. At least one of portions 22a and 22b may vary in size and/or shape. This can be done by providing separate parts that are guided in controlled relative motion, or by deforming the body 12 by reducing its dimensions or by providing points of local weakness. It can be achieved in a variety of ways, such as by allowing controlled movement of one portion relative to another.

As seen in the exemplary form of FIG. 10, body 12 has integrally formed opposed longitudinal cantilevered ends 78 and 80 toward or toward cantilevered arms 68 and 70 . In contrast, each can be deformed by moving to reduce the width W1 of the inlet opening 22a and the width W2 of the inlet opening 22b, or, as indicated by the dashed lines, these inlet openings 22a and Inlet opening 22b may be substantially eliminated to define fully enclosed passageway 18a and passageway 18b. In this exemplary form, the respective starting widths W1 and W2 of the inlet openings 22 and 24 are less than the length of the fixed portion 20 . This deformation may change the shape and dimensions of channels 18a and 18b.

In one form, this reconfiguration of body 12 can be accomplished with a conventional surgical needle holder as shown at 82 in FIG. Needle holder 82 has separate looped handles 84a and 84b that can be manipulated to move jaws 86a and 86b toward each other to provide a crimping action.

Body 12 can be positioned such that its length is captured between jaws 86a and 86b before pressure is applied, thereby simultaneously changing inlet openings 22a and 22b. Alternatively, the width of the body 12 can be gripped and crimped to individually close the inlet openings 22a and 22b in separate steps, as shown at the bottom of the body in FIG.

This crimping can produce randomly deformed shapes, or this deformation can be controlled by rational selection of shape, thickness, etc., or by locally weakening the material. . As a result, a predictable collapse or reconfigured shape is maintained without the risk of the suture tending to return to its starting configuration, which can be difficult to maintain in the desired end relationship on body 12 .

The present invention also contemplates reconfiguring body shapes other than those having the preferred body shapes described herein, or similar body shapes. For example, reconfiguring the body into a "dogbone" shape with open sockets/paths can reduce the likelihood of inadvertent separation of the operably positioned U-sutures.

To further assist in manipulating the body 12, an elongated handle 24 is attached thereto which can be grasped and moved to change the position of the body 12. As shown in FIG. The handle 24 and body 12 are movable together.

A frangible connection may be provided between the handle 24 and the body 12, as shown at 90 in FIG. can do. The rupture location may be recessed into the body 12 so that residual rough edges are not formed which can irritate the patient's tissue.

To provide the desired integrity and allow reconfiguration, body 12 is preferably made of a rigid yet deformable material such as metal, and in one preferred form, titanium alloys, pure titanium, stainless steel. Made of steel or other metal. Of course, the exact materials from which body 12 is constructed are not so limited.

13 and 14, a variant of the device is indicated at 10'. The body 12' is generally "U" shaped with a fixed portion 20' at the bottom of the "U" and two ridges projecting away from the fixed portion 20' and bounding the passageway 18' with an inlet opening 22'. It has legs, legs 96 and 98 . Legs 96 and 98 are elongated, each flared upwardly in FIG. 13, having free ends 100 and 102 spaced from the centerline, and each defining generally planar surfaces 104 and 106 for engaging tissue. do.

In FIG. 13, the U-shaped portion 30 of the elongated flexible element 28 and the body 12' are in a starting relationship, in this case a fully spaced relationship. In FIG. 13, body 12' is shown in a first state, with inlet opening 22' having a first width W5. U-shaped portion 30 and body 12' of elongated flexible element 28 are secured through inlet opening 22' into and within channel 18' until the operative relationship shown in FIG. 14 is achieved. Relatively displaced to move a portion of the U-shaped portion 30 up to the portion 20'.

Body dimension D in the region of anchor 20 is slightly smaller than the diameter of passageway 38 formed through tissue 40 .

By pulling body 12' in the direction of arrow 108, lead 110, including fixed portion 20' and U-shaped portion 30 thereagainst, can be advanced through passageway 38. As shown in FIG. When this is done, the legs 96 and 98 widen toward their free ends so that they are secured by the surface 112 surrounding the passageway 38 so that the inlet opening 22' is substantially blocked and the passageway 18 is closed. Gradually reduce the width of the inlet opening 22' until ' is substantially closed. As a result, the U-shaped portion 30 cannot move from the fixed portion 20' through the passageway 18' to and from the entrance opening 22'. Thus, accompanying movement of body 12' into passageway 38, body 12' changes from the first state to the second state.

When body 12' is fully seated, surfaces 104 and 106 abut tissue surface 42 and maintain a consistent position thereat. Wedge-shaped legs 96 and 98 securely maintain body 12' within passageway 38 by friction.

15 incorporates a roughened rib 114, corresponding to legs 96 and 98 in FIGS. A modified body, including legs 96'' and 98'', is shown at 12''.

Another form of body is shown at 12''' in FIGS. 16-18. This body 12''' is ring-shaped and can be circular or other shapes such as oval. The body 12''' extends around a first passageway 18a''' and a second passageway 18b''' and has an inlet opening 22''' communicating with the first passageway 18a'''. It has an outer perimeter wall 116 interrupted to define a .

The fixed portions 20''' cantilever project substantially diametrically from the first region 120 of the wall portion 116 to separate the paths 18a''' and 18b''' from each other.

As seen in FIGS. 16 and 17, when the body 12''' is in the first state, the free end 122 of the fixed portion 20''' is spaced apart from the outer peripheral wall 116, thereby extending the channel 18a'. A gap 124 is formed communicating between '' and path 18b'''.

16 to effectively define separate U-shaped portions 30a''' and 30b''' straddling the fixed portion 20''', as shown in FIG. Like 126, it is bent against itself. Alternatively, a single U-shaped portion may remain unbent and placed in operative relationship with body 12''' in that configuration.

A plurality of U-shaped portions 30a''' and 30b''' are both inserted through the inlet opening 22''', and first legs 34a''' and 34b''' extend through the first passageway 18a. ''' to the side 128 of the fixed part 20'''. The second legs 36a''' and 36b''' move through the first path 18a''', past the free end 122 and into the second path 18b''' to the side 128. It will reside on the opposite side 130 of the fixed part 20 .

As shown in FIG. 18, the body 12''' can be changed from the first state shown in FIGS. 17 and 18 to apply pressure between two spaced apart parts 134 and 136 to diametrically The second state is achieved by crimping the opposing regions. This crimping action deforms body 12''' and moves portion 138 relative to another portion 140 to the extent that inlet opening 22 is reduced in size or substantially completely blocked. be able to.

With a single U-shaped portion formed, its first state is achieved by first engaging the U-shaped portion with the free end of the portion 138 or the free end 124 of the fixed portion 20'''. , can be moved relative to the body 12''' from the starting relationship.

Another form of body of the present invention is shown in FIGS. 19 and 20 at 12 ⁴ ′.

The body 12 ⁴ ′ is cantilevered and fixed 20 ⁴ between the first path 18a ^{4 ′} and ^the second path 18b ^{4 ′ with the body 12 4} ′ in the first state as shown in FIG. has a substantially flat shape defining a '. With the body 12 ⁴ ′ in the first state ^of FIG ^.

A single entry opening 22 ⁴ ′ may lead suture legs 34 and 36 to paths 18a ⁴ ′ and 18b ⁴ ′, respectively, so that bottom 32 is connected to anchor 20 ⁴ . Projects across the 'upper bearing surface 21 ⁴ '.

More specifically, in changing from the starting relationship as shown in FIG. 19, the elongated flexible element 32 and body 12 ⁴ ′ are moved relative to one another to move the legs 36 into the inlet openings 22 4 ′ and 22 ⁴ ′. It is moved through the gap 142 into the path 18b ⁴ ′. The leg 34 need not move into the gap 142 but is moved through the inlet opening 22 ⁴ ′ and into the passageway 18a ⁴ ′.

When the U-shaped portion of elongate flexible element 32 and the body are placed in operative relationship, free end region 148 on cantilever 150 is moved to bridge separate portions 152 and 154 on body 12 ⁴ ′. , thereby eliminating the gap 142 and at the same time blocking the inlet opening 22 ⁴ ′.

This deformation of body 12 ⁴ ′ can be effected in a variety of ways, preferably by a crimping action such as by parts 134 and 136 as described for previous embodiments.

When body 12 ⁴ ′ is in the second state of FIG. 20, communication between paths 18a ⁴ ′ and 18b ⁴ ′ is removed, but this is not required.

The foregoing disclosures of specific embodiments are intended as illustrations of the broad concepts understood by the present invention.

Claims (42)

A U-shaped portion of an elongated flexible element may be engaged with a device such that said U-shaped portion of said elongated flexible element acts to hold a body on said device to a part of a human body. a method for
The U-shaped portion of the elongated flexible element has a base and first and second legs extending away from the base in spaced relation and having first and second lengths, respectively. and the method includes:
comprising obtaining the device;
the body of the device a) has a tissue adhering surface and an opposite surface, and b) is changeable between a first state and a second state;
a body of the device comprising a fixed portion and a first passageway extending along a portion of the body to the fixed portion and having a first inlet opening;
The method further includes relatively moving the U-shaped portion of the elongated flexible element and the body from a starting relationship to an operating relationship when the body is in the first state;
The first and second legs can straddle the securing portion and pull the bottom portion relative to the securing portion to bias the tissue adhering surface of the body toward the portion of the body. ,
Relatively moving the U-shaped portion of the elongated flexible element and the body moves at least a portion of the U-shaped portion of the elongated flexible element through the first inlet opening. moving into the first path and moving within the first path to the fixed portion;
The method further comprises changing the body to the second state when the body is in the first state and the body and the U-shaped portion of the elongated flexible element are in the operative relationship. including
The step of changing the body to the second state includes moving at least a portion of the U-shaped portion toward and through the first inlet opening to the first inlet opening. at least one of i) dimensions and ii) shape of said first inlet opening and/or said first passage so as to prevent it from moving away from said fixed part in the passage of including changing
Method. moving at least a portion of the U-shaped portion of the elongated flexible element through the first inlet opening into the first path and within the first path to the anchorage; The step of moving moves at least one of the first and second legs through the first inlet opening into the first path and within the first path to the fixed part. 3. A method of engaging a U-shaped portion of an elongated flexible element with a device according to claim 1, comprising moving. When the U-shaped portion of the elongated flexible element and the body are in operative relationship, tension is applied to the U-shaped portion of the elongated flexible element thereby pulling the bottom portion against the fixed portion. 2. The method of engaging a U-shaped portion of an elongated flexible element with a device according to claim 1, further comprising the step of biasing said tissue adhering surface of said body against said portion of said human body. 4. The method of claim 3, further comprising tensioning and securing the elongated flexible element, thereby maintaining a particular force of the tissue adhesive surface of the body against the portion of the human body. A method of engaging a U-shaped portion of an elongated flexible element with a device. the body comprises a second path extending along a portion of the body to the anchor;
The step of relatively moving the U-shaped portion and the body of the flexible element moves the first leg within the first path to the fixed portion and the second leg. 3. A method of engaging a U-shaped portion of an elongated flexible element with a device according to claim 2, comprising moving the U-shaped portion of an elongated flexible element with a device in said second path to said fixed portion. The body includes a second inlet opening spaced from the first inlet opening, and the step of relatively moving the U-shaped portion of the flexible element and the body includes: 6. A method of engaging a U-shaped portion of an elongated flexible element with a device according to claim 5, comprising moving a leg through said second inlet opening. The step of relatively moving the U-shaped portion and the body of the flexible element moves the first and second legs into the first path through the first inlet opening. 3. A method of engaging a U-shaped portion of an elongated flexible element with a device according to claim 2, comprising moving to . 6. The method of engaging a U-shaped portion of an elongated flexible element with a device according to claim 5, wherein said first and second passages are in communication with each other when said body is in said first condition. 10. The device of claim 8, wherein when said body is in said second state, communication between said first path and said second path is blocked. how to engage with further reconfiguring the body by moving a first portion of the body relative to another portion of the body, thereby changing the body from the first state to the second state; 3. A method of engaging a U-shaped portion of an elongated flexible element with a device according to claim 2, comprising: The step of moving the first portion of the body includes deforming the body, thereby changing the relationship between the first portion of the body and another portion of the body. 11. A method of engaging a U-shaped portion of an elongated flexible element with a device according to claim 10. 12. The method of engaging a U-shaped portion of an elongated flexible element with a device according to claim 11, wherein said portion of said body and another portion of said body are defined by a single piece. At least one of the first leg and the second leg in the first path is positioned in the first path at the first inlet when the body is in the second state. 3. The elongated flexible element of claim 2, wherein said inlet opening is substantially completely blocked so as to prevent movement into the opening and through said first inlet opening. A method of engaging a U-shaped portion with a device. 3. The elongated flexible element U-shaped portion of claim 2, further comprising the step of changing said body from said first condition to said second condition by crimping opposing regions of said body. A method of engaging the device. 2. The method of engaging a U-shaped portion of an elongated flexible element with a device according to claim 1, wherein said tissue adhering surface of said body has a first surface that is substantially flat. The opposite side of the body has a second substantially planar surface, the first and second substantially planar surfaces being substantially parallel first and second planes. 16. A method of engaging a U-shaped portion of an elongated flexible element according to claim 15 with a device residing within. 2. The method of engaging a U-shaped portion of an elongated flexible element with a device according to claim 1, wherein the elongated flexible element is a suture. 12. The method of engaging a U-shaped portion of an elongated flexible element with a device according to claim 11, wherein said first portion is a cantilevered portion. the device further comprising an elongated handle secured to the body;
2. The method of engaging a U-shaped portion of an elongated flexible element with a device according to claim 1, further comprising the step of changing the position of said body by manipulating said handle. 20. The method of engaging a U-shaped portion of an elongated flexible element with a device according to claim 19, further comprising the step of separating said handle from said body. 21. The U-shaped portion of the elongated flexible element of claim 20, wherein the step of separating the handle from the body comprises breaking a frangible connection between the handle and the body. How to engage. 2. The U of elongate flexible element of claim 1, further comprising reconfiguring said body using a crimping tool to change said body from said first condition to said second condition. A method of engaging a glyph with a device. 23. The method of engaging a U-shaped portion of an elongated flexible element with a device according to claim 22, wherein the crimping tool is a surgical needle holder. When the U-shaped portion of the elongated flexible element and the body are in the operative relationship, advancing the body into a passageway of the portion of the human body and concomitantly moving the body into the first condition. 2. The method of engaging a U-shaped portion of an elongated flexible element with a device according to claim 1, further comprising the step of changing from to said second state. A combination of an elongated flexible element and a device, comprising:
An elongated flexible element navigable into and configured to define a U-shaped portion protruding from said body tissue, comprising a bottom portion and a second spaced apart portion projecting away from said bottom portion. an elongated flexible element comprising first and second legs, each leg having a length extendable into the body tissue;
A device comprising a body having a tissue adhering surface and an opposing surface, the body having first and second channels and an anchoring portion having a bearing surface between the first and second channels. wherein said first and said second pathways have respective first and second inlet openings;
The body moves a) an intermediate length of the first leg into the first path through the first inlet opening, and b) an intermediate length of the second leg. moving a scabbard into said second path through said second inlet opening, and c) said bottom of said U-shaped portion overlying said bearing surface, said U-shaped portion and said body; said body and said elongated flexible element being able to move relative to each other from a starting relationship to bring into a pre-operative relationship;
said first leg by moving said first leg and said second leg away from each other in a single plane when said U-shaped portion and said body are in said pre-operating relationship; said body is configured such that said body prevents both a leg from moving out of said first path and said second leg from moving out of said second path;
Thereby, when said U-shaped portion and said body are in said preliminary operational relationship, said U-shaped portion and said body are brought into a final operational relationship in which said bottom portion of said U-shaped portion is moved relative to said bearing surface. the elongated flexible element can be moved to change the
combination. 26. The combination of claim 25, wherein said body has an S-shaped portion extending around said first pathway and said second pathway. The fixed portion has an elongated member having a length extending in a first line, a reference plane orthogonal to the line passing through both the first inlet opening and the second inlet opening. 26. The combination of claim 25, wherein the combination extends without. The fixed portion is defined by an elongated member having a length extending in a first line, and a reference plane orthogonal to the first line defines the first entrance opening and the second entrance opening. 26. A combination according to claim 25, which extends through none of the . 26. The combination of claim 25, wherein the device further comprises an elongated handle fixedly connected to the body and grippable and repositionable to move the body. 30. The combination of Claim 29, wherein the elongated handle is joined to the body by a frangible connection. 28. The method of claim 27, wherein each of said inlet openings has an inlet width, and wherein said elongate member has a length greater than said inlet width of each of said first inlet opening and said second inlet opening. combination of descriptions. 28. The combination of claim 27, wherein said first and second inlet openings are on opposite sides of a reference plane that bisects the length of said elongated member and is orthogonal to said first line. 26. The combination of claim 25, wherein said tissue adhesion surface of said body is defined by a substantially flat surface. 26. The combination of claim 25, wherein said body is made of metallic material. A combination of an elongated flexible element and a device, comprising:
An elongated flexible element navigable into and configured to define a U-shaped portion protruding from said body tissue, comprising a bottom portion and a second spaced apart portion projecting away from said bottom portion. an elongated flexible element comprising first and second legs, each of said legs having a length extendable into said body tissue;
A device comprising a body having a tissue adhesive surface, said body being a combination of a securing portion and a first path extending along a portion of said body to said securing portion. ,
wherein the U-shaped portion of the elongated flexible element and the body are relatively movable from a starting relationship to an operating relationship when the body is in the first state;
The first and second legs straddle the fixed portion and at least a portion of the U-shaped portion of the elongated flexible element extends through the first inlet opening into the first passageway. so as to move in the first path to the securing portion and pull the bottom portion relative to the securing portion to apply the first surface of the body toward the portion of the human body. It is configured to be able to
The body has a portion movable toward another portion of the body, thereby placing the body in a second state, wherein the at least a portion of the U-shaped portion extends into the first inlet opening. said first inlet opening and/or said first inlet opening so as to impede movement towards and through said first inlet opening and away from said fixed part in said first path. at least one of i) dimensions and ii) shape of one path is altered;
combination. 36. The combination of claim 35, wherein said body comprises a second passageway extending along a portion of said body to a second inlet opening. 36. The combination of claim 35, wherein said movable portion of said body is movable by deforming said body. 36. The combination of Claim 35, wherein said movable portion is a deformable cantilever. 36. The combination of claim 35, wherein said body defines a second path extending along a portion of said body to said anchor. 40. The combination of claim 39, wherein said body defines a second inlet opening towards said second pathway. The body has a second portion movable towards another portion of the body, whereby the second inlet opening and/or the second passage have a) dimensions and b 41. The combination of claim 40, wherein at least one of ) shape is altered. 36. The combination of claim 35, wherein said body is "U" shaped.

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